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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific
510(k) Number K002262
Device Name DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
Applicant
DIAMEDIX CORP.
2140 NORTH MIAMI AVE.
MIAMI,  FL  33127
Applicant Contact LYNNE STIRLING
Correspondent
DIAMEDIX CORP.
2140 NORTH MIAMI AVE.
MIAMI,  FL  33127
Correspondent Contact LYNNE STIRLING
Regulation Number866.3305
Classification Product Code
LGC  
Date Received07/25/2000
Decision Date 11/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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